INDICATIONS

Psoriatic Arthritis

Psoriasis

OTEZLA is indicated for the treatment of patients with
moderate to severe plaque psoriasis who are candidates for phototherapy or systemic
therapy.

DOSAGE AND ADMINISTRATION

Dosage In Psoriatic Arthritis And Psoriasis

The recommended initial dosage titration of OTEZLA from
Day 1 to Day 5 is shown in Table 1. Following the 5-day titration, the recommended
maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This
titration is intended to reduce the gastrointestinal symptoms associated with
initial therapy.

OTEZLA can be administered without regard to meals. Do
not crush, split, or chew the tablets.

Table 1: Dosage Titration Schedule

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6 & thereafter

AM

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

10 mg

10 mg

10 mg

10 mg

20 mg

20 mg

20 mg

20 mg

30 mg

30 mg

30 mg

Dosage Adjustment In Patients With Severe Renal
Impairment

OTEZLA dosage should be reduced to 30 mg once daily in
patients with severe renal impairment (creatinine clearance (CLcr) of less than
30 mL per minute estimated by the Cockroft–Gault equation) [see Use in
Specific Populations and CLINICAL PHARMACOLOGY]. For initial dosage
titration in this group, it is recommended that OTEZLA be titrated using only
the AM schedule listed in Table 1 and the PM doses be skipped.

HOW SUPPLIED

Dosage Forms And Strengths

OTEZLA is available as diamond shaped, film coated
tablets in the following dosage strengths:

10-mg pink tablet engraved with “APR” on one side and
“10” on the other side

20-mg brown tablet engraved with “APR” on one side and
“20” on the other side

30-mg beige tablet engraved with “APR” on one side and
“30” on the other side.

OTEZLA is available as diamond-shaped, film-coated
tablets in the following dosage strengths: 10-mg pink tablet engraved with
“APR” on one side and “10” on the other side; 20-mg brown tablet engraved with
“APR” on one side and “20” on the other side; 30-mg beige tablet engraved with
“APR” on one side and “30” on the other side.

Tablets are supplied in the following strengths and
package configurations